LeGoo® LG250

Primary DI
20358468019046
Brand
LeGoo® LG250
Company
GENZYME CORPORATION
Model
LG250
Device description
Occluder, Internal Vessel, Temporary
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBCOccluder, internal vessel, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBCOccluder, Internal Vessel, TemporaryUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20358468019046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2035846801904620358468019046

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding solution kitA collection of sterile devices intended as an alternative to vascular clamping to interrupt local blood flow through transient intraluminal obstruction during surgery, suturing of blood vessels, or interventional vascular procedures. It includes a liquid polymer (e.g., poloxamer) that is injected into a vein/artery, and devices to contain/administer the solution (e.g., pouch, syringe, injection cannula or catheter). The solution typically has reverse thermal characteristics (i.e., liquid at room temperature and gelled at body temperature) enabling the formation of an in vivo plug that occludes the vessel; it eventually dissolves or is purposely dissolved. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume2.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)661-1471brian.nelson@genzyme.com
+1(508)271-3304paul.dawidczykjr@genzyme.com

Regulatory Flags#

DUNS number
078893293
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00358468430120Seprafilm®4301-022014-09-24
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00358468638014Seprafilm® 4-section6380-012014-09-24
00358468664112Seprafilm® Single Site6641-012014-09-24
00358468664211Seprafilm® Small Incision6642-012014-09-24
00358468000071GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US7626172022-10-19
00358468000057NEOGAA AVALGLUCO 100MG/20ML MEDSU VL1 US7853612020-07-01
00358468000064OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US7853622020-07-01
00358468000019ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US7626182020-06-01
00358468000026MYOZYME 50MG/10ML MEDSU VL1 DIAG US7626192020-06-01
00358468000033FABRAZYME 35MG/7ML VL1 DIAG US7626202020-06-01
00358468000040CEREZYME 400IU MEDSU VL1 DIAG US7626212020-06-01
20358468019114Synvisc-One®0024012014-09-24
00358468019103Synvisc®0023902014-09-25
20358468019039LeGoo® LG100LG1002014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20801902134992ARROWTELEFLEX INCORPORATEDOBC2017-05-27
20358468019039LeGoo® LG100GENZYME CORPORATIONOBC2014-09-24